Clinical trial evaluating two ventilator settings in Corona virus related severe lung diseases ( known as ARDS)

Driving pressure guided positive end expiratory pressure (PEEP) strategy Vs physician guided PEEP (ARDSnet protocol) in mechanical ventilation for Acute respiratory distress syndrome (ARDS) in COVID-19 patients: a prospective randomised controlled trial.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/05/025071

Enrollment

Registered

2020-05-08

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Interventions

Intervention1: Lowest driving pressure guided PEEP: Initial PEEP would be kept at 5 cmH2O and driving pressure would be noted. PEEP would be stepped up in increments of 1 and the corresponding Ã?â?P

Eligibility

Inclusion criteria

Inclusion criteria: All adult patients > 16 years of age of either sex fulfilling WHO case definition of COVID-19 positive with ARDS (Berlin Criteria) needing invasive mechanical ventilation

Exclusion criteria

Exclusion criteria: Relatives who refuse to give consent or have unproven/suspected COVID-19 infection age BMI 40kg/m2 pregnant increased intracranial pressure severe neuromuscular disease severe chronic respiratory disease severe chronic liver disease active malignancy

Design outcomes

Primary

Measure	Time frame
Difference in the area under the curve (adjusted to survival time) for MurrayÃ¢â?¬â?¢s lung injury score between the two groups in the first 4 days.Timepoint: The first 4 days during ICU stay and mechanical ventilation	—

Secondary

Measure	Time frame
Difference in following parameters between the two groups- PaO2/FiO2 (P/F) ratio pH, pCO2, base excess, lactate Plateau pressure, static compliance SOFA score Vasopressor requirement Need for sedation and neuromuscular blockade Reintubation Rates Number of days of ventilation and number of ventilator free days Number of ICU days and number of ICU free days Incidence of pneumothorax Mortality at day 7, day 14 and day 28. Timepoint: On all days of ICU admission. Mortality would be assessed on all days till 28 days	—

Measure

Time frame

Difference in following parameters between the two groups- PaO2/FiO2 (P/F) ratio pH, pCO2, base excess, lactate Plateau pressure, static compliance SOFA score Vasopressor requirement Need for sedation and neuromuscular blockade Reintubation Rates Number of days of ventilation and number of ventilator free days Number of ICU days and number of ICU free days Incidence of pneumothorax Mortality at day 7, day 14 and day 28. Timepoint: On all days of ICU admission. Mortality would be assessed on all days till 28 days

—

Countries

India

Contacts

Public ContactDr Ajisha Aravindan

All India Institute of Medical Sciences

ajishaa@gmail.com9810597276

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026